Effect of Albendazole Dose on Clearance of Filarial Worms

Summary

This study, conducted in Mali, West Africa, will determine whether a new treatment regimen
for lymphatic filariasis can eliminate the disease more quickly than the standard regimen.
Lymphatic filariasis is caused by infection with very small filarial worms called Wuchereria
bancrofti that are spread by mosquitoes. The disease can cause swelling of the arms, legs,
breast and genitalia and can progress to permanent swelling of the legs or arms called
elephantiasis. Currently, patients in Mali are treated with a single dose of 400 mg of
albendazole plus two doses of 200 mcg/kg of ivermectin each year. This study will use a
regimen of 800 mg of albendazole twice a year plus 200 mcg/kg of ivermectin twice a year for
2 years. The study will see if the new regimen is more effective in lowering the numbers of
Wuchereria bancrofti in the blood and will examine the effects of the two treatments on the
adult worms living in the lymph system.

Healthy people between 14 and 65 years of age who live in the Mali village of N'Tessoni and
are infected with Wuchereria bancrofti may be eligible for this study. Candidates are
screened with a medical history, a brief physical examination and blood tests to check for
infection with Wuchereria bancrofti and to measure white blood cell counts.

Participants undergo the following procedures:

-First visit

Ultrasound examination to look for filarial worms in the body.

Random assignment to receive either standard treatment or the experimental regimen

Description

Albendazole and ivermectin are currently used in combination for annual mass treatment of
lymphatic filariasis in Africa. Although the drugs have been donated, the cost of such
programs is very high and has proven to be a major impediment to the success of programs in
many countries with limited financial resources. Data from albendazole treatment of other
filarial infections and one study comparing single to multi-dose DEC/albendazole in
lymphatic filariasis suggest that increased dose and/or frequency of albendazole dosing may
be more effective in clearing microfilariae. Furthermore, the optimal dose of ivermectin for
the treatment of lymphatic filariasis is greater than that being used in the current mass
treatment program. In this study, 50 volunteers with microfilaremic Wuchereria bancrofti
infection will be randomized to receive standard annual therapy (albendazole 400 mg +
ivermectin 150 mcg/kg) or semiannual therapy with an increased albendazole dose (albendazole
800 mg + ivermectin 400 mcg/kg). If adequate numbers of microfilaremic subjects are
recruited, an additional 25 volunteers will receive annual therapy with the increased dose
combination. Microfilarial levels, as well as measures of adult worm burden (circulating
antigen, ultrasound identification of adult worm nests) will be followed every six months
for three years to assess the effects of the treatments.

Study Design

Primary Purpose: Treatment

Conditions

Lymphatic Filariasis

Intervention

Albendazole, Ivermectin

Location

University of Bamako, Faculty of Medicine, Pharmacy and OdontostomatologyBamakoMali

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Medical and Biotech [MESH] Definitions

Elephantiasis, Filarial

Parasitic infestation of the human lymphatic system by WUCHERERIA BANCROFTI or BRUGIA MALAYI. It is also called lymphatic filariasis.

Neglected Diseases

Diseases that are underfunded and have low name recognition but are major burdens in less developed countries. The World Health Organization has designated six tropical infectious diseases as being neglected in industrialized countries that are endemic in many developing countries (HELMINTHIASIS; LEPROSY; LYMPHATIC FILARIASIS; ONCHOCERCIASIS; SCHISTOSOMIASIS; and TRACHOMA).

Lymphatic Metastasis

Transfer of a neoplasm from its primary site to lymph nodes or to distant parts of the body by way of the lymphatic system.

Albendazole

A benzimidazole broad-spectrum anthelmintic structurally related to MEBENDAZOLE that is effective against many diseases. (From Martindale, The Extra Pharmacopoeia, 30th ed, p38)

Lymphatic Abnormalities

Congenital or acquired structural abnormalities of the lymphatic system (LYMPHOID TISSUE) including the lymph vessels.

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